Graft-vs.-Host Disease (GVHD) is one of the major limitations of allogeneic hematopoietic
stem cell transplants (HSCT). This complication is major cause of morbidity and mortality
and is thought to be initiated by activation of donor T-cells through recognition of
"foreign" cells resident in the transplant recipient. Acute GVHD is associated with damage
to the liver, skin, gastrointestinal tract and mucosa. Moderate to severe GVHD Grades II-IV
occurs in 30-50% of matched related HSCTs and 50-70% of unrelated donor recipients. Severe
GHVD requires intense immunosuppression involving steroids and additional agents to get it
under control, and patients may develop severe infections as a result of such
immunosuppression. An agent or cell therapy that could reduce the incidence and/or severity
of GVHD without increasing relapse or infectious risk in HSCT patients would provide
substantial benefits.

Inclusion Criteria:

- Patients of either sex aged 18-65 years of age

- Diagnosis of acute myeloid or lymphoblastic leukemia (second or subsequent remission,
if not in remission, then <20% bone marrow blasts), chronic myelogenous leukemia
resistant to or intolerant of tyrosine kinase inhibitor therapy (accelerated phase,
first chronic phase with TKI resistance, or second chronic phase), or myelodysplastic
syndrome (intermediate/high or high risk by International Prognostic Scoring System
(IPSS), lower risk by IPSS with patient having progressed after prior therapy.
Complete remission is defined as the absence of blasts in the peripheral circulation
at the time of enrollment and <5% blasts in the marrow within 28 days of enrollment.

- Hepatic function: Screening ALT or AST ≥3x than the upper limit of normal for the
laboratory OR total bilirubin ≥2.0 mg/dL (Exception: acceptable if patient is
identified with pre-existing condition e.g., Gilbert's disease that will contribute
to baseline elevations of bilirubin)

- Pulmonary function: FEV1, FVC, DLCO ≤50% predicted

- Cardiac function: left ventricular ejection fraction ≤50%

- Patient received an investigational agent within 30 days prior to transplant

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